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Dicyclomine Pregnancy and Breastfeeding Warnings

Brand names: Bemote, Bentyl, Bentyl Syrup, Byclomine, Di-Spaz, Dibent, Dicyclocot, Dilomine

Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.

Dicyclomine Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: B

Animal studies in rats and rabbits have revealed no evidence of harm to the fetus with this drug. Adequate and well-controlled studies have not been conducted in pregnant women.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Dicyclomine Breastfeeding Warnings

Use should be avoided.

Excreted into human milk: Yes
Excreted into animal milk: Data not available

Comments: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

A single case has been reported of a breast-fed 12 day old infant who developed apnea whose mother was receiving dicyclomine. A causal relationship between dicyclomine and apnea could not be confirmed. Similar adverse reactions have occurred with direct administration of dicyclomine to infants.

See references

See also

References for pregnancy information

  1. Golden SM, Perman KI (1980) "Bilateral clinical anophthalmia: drugs as potential factors." South Med J, 73, p. 1404-7
  2. Morelock S, Hingson R, Kayne H, Dooling E, Zuckerman B, Day N, Alpert JJ, Flowerdew G (1982) "Bendectin and fetal development. A study of Boston City Hospital." Am J Obstet Gynecol, 142, p. 209-13
  3. Shapiro S, Heinonen OP, Siskind V, Kaufman DW, Monson RR, Slone D (1977) "Antenatal exposure to doxylamine succinate and dicyclomine hydrochloride (Benedectin) in relation to congenital malformations, perinatal mortality rate, birth weight, and intelligence quotient score." Am J Obstet Gynecol, 128, p. 480-5
  4. Miklovich L, van den Berg BJ (1976) "An evaluation of the teratogenicity of certain antinauseant drugs." Am J Obstet Gynecol, 125, p. 244-8
  5. Wheatley D (1977) "Treatment of pregnancy sickness." Br J Obstet Gynaecol, 84, p. 444-7
  6. Harron DW, Griffiths K, Shanks RG (1980) "Debendox and congenital malformations in Northern Ireland." Br Med J, 281, p. 1379-81
  7. DonnaiD, Harris R (1978) "Unusual fetal malformations after antiemetics in early pregnancy." Br Med J, 1, p. 691-2
  8. Fleming DM, Knox JD, Crombie DL (1981) "Debendox in early pregnancy and fetal malformation." Br Med J (Clin Res Ed), 283, p. 99-101
  9. Williams J, Watkins-Jones R (1984) "Dicyclomine: worrying symptoms associated with its use in some small babies." Br Med J (Clin Res Ed), 288, p. 901
  10. Patterson DC (1977) "Congenital deformities associated with Benedectin." Can Med Assoc J, 116, p. 1348
  11. Cordero JF, Oakley GP Jr (1983) "Drug exposure during pregnancy: some epidemiologic considerations." Clin Obstet Gynecol, 26, p. 418-28
  12. Huff PS (1980) "Safety of drug therapy for nausea and vomiting of pregnancy." J Fam Pract, 11, p. 969-70
  13. Correy JF, Newman NM (1984) "Debendox withdrawn." Med J Aust, 140, p. 796-7
  14. Altman PM (1984) "Debendox withdrawn." Med J Aust, 140, p. 119
  15. Correy JF, Newman NM (1981) "Debendox and limb reduction deformities." Med J Aust, 1, p. 417-8
  16. Gibson GT, Colley DP, McMichael AJ, Hartshorne JM (1981) "Congenital anomalies in relation to the use of doxylamine/dicyclomine and other antenatal factors: an ongoing prospective study." Med J Aust, 1, p. 410-4
  17. Sheffield LJ, Batagol R (1985) "The creation of therapeutic orphans--or, what have we learnt from the Debendox fiasco?" Med J Aust, 143, p. 143-7
  18. Maling TJ (1984) "Debendox: a statement from the New Zealand Adverse Drug Reactions Committee." N Z Med J, 97, p. 203-4
  19. Harris R, Donnai D (1980) "Debendox and the media." Br Med J, 280, p. 480-1
  20. Mellor S (1978) "Fetal malformation after debendox treatment in early pregnancy." Br Med J, 1, p. 1055
  21. Smithells RW, Sheppard S (1978) "Fetal malformation after debendox treatment in early pregnancy." Br Med J, 1, p. 1055-6
  22. Dickson JH (1977) "Congenital deformities associated with bendectin." Can Med Assoc J, 117, p. 721-2
  23. Congenital Abnormalities Sub-Committee of the Australian Drug Evaluation Committtee (1980) "Debendox in pregnancy." Med J Aust, 1, p. 197
  24. Gordon I (1986) "Debendox." Med J Aust, 144, p. 51-2
  25. Mitchell AA (1986) "Debendox." Med J Aust, 144, p. 52
  26. (2002) "Product Information. Bentyl (dicyclomine)." Aventis Pharmaceuticals
  27. Cerner Multum, Inc. "UK Summary of Product Characteristics."

References for breastfeeding information

  1. Briggs GG, Freeman RK, Yaffe SJ.. (1998) "Drugs in Pregnancy and Lactation." Baltimore, MD: Williams & Wilkins
  2. (2002) "Product Information. Bentyl (dicyclomine)." Aventis Pharmaceuticals
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics."

Further information

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